Overview
This is a high-level quality assurance role focused on ensuring compliance with Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) regulations. The ideal candidate will have extensive experience in the biotech/pharmaceutical industry, particularly in GCP quality roles or clinical monitoring.
The responsibilities of this position include:
- Representing QA for the Clinical and Non-Clinical departments
- Implementing and maintaining a Quality Management System (QMS) to support GCP/GLP activities
- Driving and maintaining an appropriate level of compliance to the QMS
Additionally, the selected individual should possess strong leadership skills, be able to manage suppliers/subcontractors/clinical vendors and CROs, and ensure inspection/audit readiness in the area of expertise.
Qualifications include a Bachelor's degree in a scientific or life sciences field, with a minimum of 10 years of experience in the biotech/pharmaceutical industry in a GCP quality role, clinical monitoring, or equivalent.